Press Release 2012

Company targets clinical trial of antifibrotic drug in 2013

Japan’s leading diversified materials manufacturer, Nitto Denko Corporation, today announced that a basic patent regarding the company’s epoch-making antifibrotic therapy has been successfully registered in the USA. Nitto Denko has been developing antifibrotic drugs in collaboration with Professor Yoshiro Niitsu at Sapporo Medical University since 2008, and has already been granted this patent in Japan, China and Australia.

This patent covers various DDS (Drug Delivery Systems) that includes antifibrotic drugs, coupled with targeting agents for the cells that are responsible for disease. This patent should lead to the world’s first complete cure of organ fibrosis, which is expected to give a significant boost to the value of Nitto Denko’s patent portfolio.

Recently Nitto Denko has developed new drug and drug delivery materials which satisfy both efficacy and safety perspectives. Nitto Denko plans practical applications firstly for a liver cirrhosis drug, by applying an IND (Investigational New Drug) to the US FDA (Food and Drug Administration) by the end of 2012, followed by the initiation of clinical trial studies in 2013.
Hereafter, Nitto Denko aims to expand efforts and achieve significant progress in order to develop new drugs for inveterate diseases including fibrosis.

Molecular targeting DDS is for delivering therapeutic agents directly and specifically to the cells that cause diseases. In the future it is anticipated that highly efficacious treatments with less side-effects for the diseases would be available that is still difficult to treat now. The antifibrotic therapy Nitto Denko is currently developing was discovered by Prof. Yoshiro Niitsu and his group in Sapporo Medical University, then combined with Nitto Denko’s new DDS technologies. Nitto Denko expects that this treatment can be applied to various organ fibrosis including liver cirrhosis and other intractable diseases.

Future Plan

Currently, non-clinical studies are being conducted and Nitto Denko aims to submit an IND application in December 2012, followed by initiation of clinical study phase-1 in USA in 2013. Then, clinical trial phase-2a is planned to be completed in 2015. From phase-2b, we may potentially collaborate with other partners with the aim of launching a new drug in 2018 or after.

About Nitto Denko

Founded in 1918, Nitto Denko is Japan’s leading diversified materials manufacturer offering over 13,000 high-value-added products to the global market. Nitto Denko’s strength lies in its flexibility to add diverse functionalities to sheets, films and other materials, fully utilizing its core technologies such as polymer synthesis, adhesion and coating. The Nitto Denko group’s wide spectrum of specialities include optical films for liquid crystal displays, automotive materials, reverse osmosis membranes for seawater desalination, transdermal drug delivery systems, and much more. Those existing expertise related to transdermal drug delivery systems and therapeutic nucleic acid manufacturing shall be utilized for the development of new drugs and Molecular targeting DDS technology. Nitto Denko is traded on the Tokyo Stock Exchange (TSE). Total net sales in fiscal year 2010 amounted to US$7.7 billion. The company consists of 107 subsidiaries across the globe and employs over 33,000 people.